code of conduct 2012 - ifpma...translated by arabera traduções | héctor hernán martínez baeza...

1C O D E O F C O N D U C T

R E V I E W 2 0 1 2

2 I N T E R F A R M A

Translated by Arabera Traduções | Héctor Hernán Martínez Baeza


Interfarma’s Code of Conduct has been in effect since July 1, 2012. The document, whi-

ch we now present with great satisfaction to authorities, society, the medical class and

other health professionals, considers the results of an in-depth and detailed revision

that began in 2007 and is not fi nished in this edition. It will always be a continuous

process of improvement.

The new text goes beyond that. In a pioneer fashion, it incorporates the terms of an

unprecedented understanding that our entity reached with the Federal Council of Me-

dicine signed last February.

Therefore, the provisions, now transformed into rules for the professionals at our 43

affi liated companies, include the most rigorous ethical care, obligations and prohi-

bitions that, in the mutual judgment of the CFM and Interfarma, should clearly and

transparently preside over good relationship practices among the medical class, health-

care professionals and the Pharmaceutical Industry.

For us at Interfarma, the Code of Conduct is more than just a text. It is a document

that governs our daily practice and our greater commitment with society and with the

country: act ethically. Thus, only those companies that respect and follow the Code can

become members of our entity. And, in the event of noncompliance with the rules, the

Code itself establishes the mechanisms that lead to punishment.

With this initiative, we hope to help patients, doctors, authorities and professionals

transform public health and the relations that exist therein in our Country in areas of

clarity, transparency, respect for laws and ethics.

Preface

Antônio BrittoPresidente Executivo

Theo Van der LooPresidente do Conselho Diretor


Pronouncement by the President of the Federal Council of Medicine – CFM – Dr. Roberto Luiz d´Avila, during the ceremony for signing the term of positioning in defense of good relationship practices between the medical class and the pharmaceutical industry

“From the outset, Interfarma has demonstrated a receptiveness and willingness to cons-

truct this document. And if that had not existed, we would not be here now, even if it

had been 10 years after my history and two and a half years since I assumed as President

of the Council, seeking this understanding.

I think it is a victory for all. It is a victory for society that now moves forward with this

transparent relationship with the industry; society now begin to understand and to rea-

lize that in reality there is no special treatment and there are no reasons to distrust that

medical prescription; that the medical prescription will be fi lled with total independen-

ce, with total belief in the effi cacy, in the effi ciency of that medication and not soiled by

obscure interests of both parties, of doctors and the industry itself.

I believe that above all else it is a victory of society and a victory of the doctors who now

also understand this relationship without submitting to gaining any advantage. The

professional now has a clear conscience that he is doing what is best for his patient, and

on the other hand, I think it is also good for industry. I cannot speak for the industry,

but I believe that for the industry these criteria are very clear and that this relationship

also is established on a solid and a trusting base, especially one of transparency.”


PreambleThe pharmaceutical industry is constantly renewing its quest for innovations that trans-

form themselves into therapeutic options for the growing challenges in public health,

providing dynamism to a sector that continuously recycles its concepts and broadens

horizons for patients and healthcare professionals. In line with the legitimate expecta-

tions of the Brazilian society, the pharmaceutical industry tries not only to perform its

fundamental mission of offering better, more effi cient drugs, but also to reinforce its

uncompromising defense of ethical principles that give the much needed credibility

and transparency to the research, development, distribution, provision, and promotion

of drugs in the country.

INTERFARMA’s Associated Companies and those that spontaneously choose to be

bound by the terms of this Code of Conduct (hereinafter referred to as “Companies”)

acknowledge the importance of free competition, free initiative, and, above all, are

committed to managing their activities within ethical standards compatible with the

objective of consolidating a Brazilian pharmaceutical market that is aware of its respon-

sibilities towards patients, consumers, physicians, public offi cials, non-governmental

organizations, and all other related professionals.


IndexDefi nitions ......................................................................... 09

Structure of this Code ................................................... 10

Chapter 1

General rules for the

pharmaceutical sector ......................................11

Section 1 .............................................................................. 12

Fundamental Principles

Section 2 .............................................................................. 14

Relationship with Public Offi cials

and Government Authorities

Section 3 .............................................................................. 14

Interactions and Relationship with Patient

Associations

Section 4 .............................................................................. 16

Adherence to the Code and Enforcement

in Healthcarerelated Areas

Section 5 ............................................................................. 17

Contracting of Specialized Services

in Healthcare

Section 6 .............................................................................. 19

Congresses, Symposiums, Seminars,

and Other Events

Section 7 .............................................................................. 23

Promotional Materials

Section 8 .............................................................................. 25

Drug-related Activities at Points of Sales

Section 9 .............................................................................. 26

Communication on New Drugs and Indications

not Approved by ANVISA (Offl abel)

Section 10 ........................................................................... 27

Off er of Gifts

Chapter 2

Rules related to drugs subject to a

physician’s prescription ....................................29

Section 11 .......................................................................... 30

Distribution of Free Samples

Section 12 ........................................................................... 31

Visit to Healthcare Professionals

Section 13 ........................................................................... 32

Donations and Other Contribution

for Healthcare Institutions, Bodies,

Associations, and Companies

Chapter 3

Rules related to Over-The-Counter

Drugs (OTC) ........................................................35

Section 14 ........................................................................... 36

Over-The-Counter Drugs (OTC)

Section 15 ........................................................................... 38

Direct Contact with Consumers


Chapter 4

Rules for confl ictresolution ..............................39

Section 16 ........................................................................... 40

Application and Eff ectiveness of Code

of Conduct Rules

Section 17 ........................................................................... 41

Ethics Committee

Section 18 ........................................................................... 42

Penalties

Annex

Regulation of the Ethics Committee ................45

1. Preliminary provisions ............................................. 46

2. Start of the investigation procedure .................. 47

3. The Ethics Committee ............................................. 48

4. Claim of impediment of a member .................... 50

5. Evidence ...................................................................... 51

6. The trial session ........................................................ 52

7. The Decision of the Ethics Committee .............. 54

8. The appeal procedure ............................................. 56

9. Eff ectiveness of the Decision of the

Ethics Committee ...................................................... 56

10. Costs .............................................................................. 57

11. Confi dentiality ........................................................... 57

12. Final provisions .......................................................... 57


Defi nitions

The following defi nitions are adopted for the purposes of this Code of Conduct:

Healthcare Professionals: Professionals qualifi ed to prescribe or dispense drugs, inclu-

ding physicians, dentists and pharmacists.

Healthcare-related Professionals: Persons who may infl uence the prescription, dis-

pensation or suggestion of drugs, both in the private sector and as public offi cials,

including, but not limited to nurses, physiotherapists, audiologists, biomedicine pro-

fessionals, pharmacovigilance professionals, students of medicine, pharmacy, nursing,

physiotherapy, audiology, drugstore attendants, members of product standardization

commissions, employees and agents of public or private hospitals, clinics, and other

entities related to patients or healthcare institutions, associations or companies.

Healthcare Institutions, Bodies, Associations, and Companies: All those that, directly

or indirectly, both in the private sector and as part of the government, take part in he-

althcare or supporting activities, including those representative of physicians, pharma-

cists, and patients, regulatory agencies, the Ministry of Health, Departments of Health

at state or local levels, or any other private entity or governmental body that purchases

drugs.

Public Offi cial: Any person who, permanently or temporarily, with or without remune-

ration, performs the duties of a public position, job or role at any governmental body

or entity.

Promotional Material: Any material produced by Companies with the purpose of pro-

moting their products and devices, regardless of the media that is used.

Free Sample: Any drug distributed to Prescribing Healthcare Professionals without re-

muneration.


Structure of this Code

With the purpose of better systematizing the rules set forth in this Code, its provisions

were divided as follows:

Chapter 1 – General rules for the pharmaceutical sector;

Chapter 2 – Rules related to drugs subject to a physician’s prescription;

Chapter 3 – Rules related to Over-The-Counter Drugs (OTC);

Chapter 4 – Rules for confl ict resolution


Chapter 1General rules for the pharmaceutical sector


Section 1Fundamental Principles

1.1.

The following fundamental principles shall be observed by Companies bound by this

Code when promoting their drugs and interacting with Public Offi cials and Healthcare

Institutions, Bodies, Associations, and Companies:

1.1.1. Relationship Bases: The relationship with Healthcare Professionals and

Healthcare-related Professionals shall be based on an exchange of information that

helps a permanent development of healthcare and pharmaceutical care, thus con-

tributing to provide patients with access to increasingly effi cient and safe therapies.

1.1.2. Product Information: Product information shall be balanced, true, complete,

updated, and, when applicable, supported by scientifi c evidence. The promotion of

drugs based on controversial or unsupported information is contrary to this Code’s

principles.

1.1.3. Autonomy of Healthcare Professionals: Companies bound by this Code shall

not, directly or indirectly, offer, promise or give awards, gratuities or advantages of

any nature linked to the prescription, use, promotion, recommendation, suggestion

or endorsement of drugs. Any action that may be perceived as undue interference on

the autonomy of Healthcare Professional or Healthcare-related Professionals shall

be promptly interrupted, without prejudice to the possible determination of liability

pursuant to the rules of this Code and to the legislation in force.

1.1.4. Proper Usage of Drugs: Promotional actions shall have the purpose of divulg-

ing the correct and proper indications of a drug.


1.1.5. Indications not approved by ANVISA (Brazilian Health Surveillance Agency)

(Offl abel): recommendations for the use of drugs that are not in strict correspon-

dence with indications previously approved by Brazilian sanitary authorities are

hereby forbidden, except when destined specifi cally to the spreading of knowledge

among the scientifi c community, as set forth in Section 9 below.

1.1.6. Transparent Relationships: Disguised relationships with Healthcare Profes-

sionals, Healthcare-related Professionals, Public Offi cials, and Healthcare Institu-

tions, Bodies, Associations or Companies are not admissible. Actions involving do-

nations to or the hiring of professionals to provide specialized services, assessment,

researches or studies shall always be supported by social, scientifi c or continued

education demands that are clearly identifi able and solidly justifi able, being always

backed by a written agreement signed by the parties.

1.1.7. Liability: INTERFARMA’s Associated Companies and those that agree to be

bound by the ethical standards set forth herein are responsible for enforcing the

rules of this Code of Conduct in all actions that they perform, directly or indirectly,

before Healthcare Professionals, Healthcare-related Professionals, Public Offi cials,

and Healthcare Institutions, Bodies, Associations or Companies. These Companies

are also liable for actions taken by third parties, especially distributors and contrac-

tors, whenever these take action under their guidance or mandate, pursuant to the

law.

1.1.8. Legislation in Force: without prejudice to the provisions of this Code, the pro-

motion of drugs and other interaction activities with Public Offi cials, and Healthcare

Institutions, Bodies, Associations or Companies shall be regulated by the laws, de-

crees, ordinances, resolutions, and rules set forth by the administering authorities on

the matter, and the most restrictive rule shall prevail.


Section 2Relationship with Public Offi cials and Government Authorities

2.1.

The Companies bound by this Code and any of their offi cers, directors, employees or

representatives shall not, directly or indirectly:

2.1.1. Make any offer, promise or authorize payments and/or donations of any

amount in money or other items of value to Public Offi cials or representatives from

Healthcare Institutions, Bodies, Associations, and Companies, with the purpose of

inducing the benefi ciary to take or not to take any action in violation of their legal

obligations; and

2.1.2. Take advantage of any offer, promise or authorization of payment and/or do-

nation as a means to obtain and/or retain business and/or undue advantages before

government bodies.

Section 3Interactions and Relationship with Patient Associations

3.1.

Companies bound by this Code may interact with Patient Associations and other simi-

lar organization with the purpose of raising the population’s awareness of health-rela-

ted issues and/or of providing the public with proper information on the treatment,

prevention, and diagnosis of diseases.


3.2.

On their interactions with Patient Associations, the Companies shall ensure that their

relationship is clear and transparent, striving so that all their actions are in conformity

with the rules set forth in this Code of Conduct.

3.2.1. The Companies shall keep a list of Patient Associations who have received fi -

nancial support and/or any other indirect/non-fi nancial aid; such list shall contain

a brief description of the nature of each project and the corresponding value or ben-

efi t, person in charge, scope, term, and other information deemed relevant.

3.3.

The Patient Associations shall be entitled to total independence regarding the informa-

tive materials developed by them, while the Companies may, upon request, offer tech-

nical and scientifi c information regarding their fi eld of specialization. The Companies

may not infl uence on the development of informative materials by the Patient Associa-

tions with the purpose of obtaining commercial advantages for themselves or for their

affi liates, subsidiaries, and/or associated companies.

3.4.

The following requirements shall be taken into account by Companies supporting Pa-

tient Associations:

3.4.1. The support to Patient Associations shall not be conditioned to any retribu-

tion to the supporting company other than their institutional promotion, and shall

always be backed by a written agreement, regardless of value.

3.4.2. No Company shall request, condition or demand exclusivity in turn for their

support to a Patient Association or to any of the latter’s programs.

3.4.3. In respect to the autonomy of Patient Associations, the Companies shall not be

responsible for the permanent payment of the Patients Associations administrative

expenses, except in exceptional cases, thus considered those of recently established

entities in a proven state of need, when the allocation of resources for rent, person-

nel and routine material payments shall be allowed, as long as for a term no longer

than three (3) years.


3.5.

Companies bound by this Code shall always refuse requests from Patient Associations

and their members for counseling in personal medical issues (i.e., “Is this drug suita-

ble for me?”); however, the provision of general information on their own products is

allowed, such as answers to questions about indication and dosage in accordance with

the respective sanitary record. In any case, the Company shall advise the patient to seek

proper medical guidance.

Section 4Adherence to the Code and Enforcement in Healthcare-related Areas

4.1.

INTERFARMA’s Associated Companies acknowledge self-regulation as the preferential

means to solve controversies arisen in the segment represented by them and, for such,

grant the required legitimacy to judging bodies and agree to abide by their decisions

whenever violations of the rules in force are identifi ed, as set forth in Chapter 4 below.

4.2.

This Code’s provisions may also be extended to pharmaceutical companies not associa-

ted with INTERFARMA or to stakeholders in areas related to the defense and protection

of health, in which case they shall be subject to the rules in force in what applies to

them.


Section 5Contracting of Specialized Services in Healthcare

5.1.

The Companies may hire Healthcare Professionals or Healthcare-related Professionals

to provide services compatible with their qualifi cation or specialization area, and may

compensate these professionals according to the complexity and importance of their

professional services, in addition to expenses, provided they are reasonable, such as

transport, accommodation, and food, limited to the period during which the professio-

nals provides their services.

5.2.

The contracting of Healthcare Professionals or Healthcare-related Professionals shall

abide by the transparency and ethical principles set forth in this Code, observing the

following:

5.2.1. existence of a document proving de agreement between the Parties with a de-

scription of the nature of services to be provided and the compensation criteria for

such services;

5.2.2. existence of legitimate interest in the contracted services, established clearly

and previously identifi ed;

5.2.3. guarantee of unconditional respect for the technical-scientifi c independence of

the hired professional;

5.2.4. presentation of candidate selection criteria compatible with the identifi ed ob-

jective, also ensuring that the people in charge of selection have the knowledge nec-

essary to evaluate if the selected professionals meet the previously defi ned criteria;

5.2.5. a number of hired professionals not higher than that which is reasonably re-

quired to meet the identifi ed objective;


5.2.6. relevant records kept by the Company and effective usage of the services pro-

vided;

5.2.7. meetings with hired professionals carried out at locations compatible with the

type of service to be carried out. The main reason for such meetings shall always be

related to the provision of services, while social gatherings shall have a clearly sec-

ondary character, considering the time and relevance attributed to them; and

5.2.8. transport, accommodation, and food expenses compatible with the event’s cir-

cumstances and preferably paid directly to the travel agent or to the service provider.

In case of need to reimburse such expenses to the Healthcare Professional or to the

Healthcare-related Professional, which shall happen only in exceptional cases, the

Company shall make sure that they are backed by fi scal (or equivalent) documents

and that they do not include any expense or payment made in benefi t of family

members, companions or persons invited by the hired professional.

5.3.

The hiring of Healthcare Professionals or Healthcare-related Professionals who perform

or have performed the role of Public Offi cials shall comply with the relevant rules, ob-

serving permanent or temporary impediments set forth by legislation.


Section 6Congresses, Symposiums, Seminars, and Other Events

Sponsoring events organized by medical associations or other enti-ties

6.1.

The Companies may take part in symposiums, congresses, seminars, and other scientifi c

or educational events that aim at providing means of development to Healthcare Pro-

fessionals or Healthcare-related Professionals.

6.1.1. The acquisition of quotas to participate in congresses, symposiums, seminars,

and other events shall be by means of written agreements with the company or

organizing entity, and shall not be conditioned to any type of interference with the

agenda, objectives, location, lecturer selection or other aspects related to the event.

The contracting of Healthcare Professionals or Healthcare-related Professionals to act as lecturers in seminars and other events

6.2.

Healthcare Professionals and Healthcare-related Professionals hired to act as lecturers

in symposiums, congresses, meetings, conferences or any other events shall be entitled

to complete autonomy and freedom for formulate their opinions and analyses.

6.3.

The Companies shall take action so that, before their presentation begins, the attending

audience is properly informed of possible ethical confl icts to which the hired professio-

nal may be subject, thus ensuring that the public is able to critically and independently

evaluate the reach of the information they are provided.


Participation of Healthcare Professionals or Healthcare-related Pro-fessionals in scientifi c events by invitation of a Company

6.4.

The Companies may invite Healthcare Professionals and Healthcare-related Profes-

sionals to participate in symposiums, congresses, and other national or international

events, whose main purpose is to spread scientifi c knowledge, by paying – or reimbur-

sing – expenses related exclusively to transport, meals, accommodation, and entry fees

charged by the organizing entity.1

6.5.

The Companies shall use objective and plural criteria to identify the invited Healthcare

Professionals and Healthcare-related Professionals; invitations based solely on com-

mercial criteria shall not be allowed.

6.6.

The following factors indicate that the participation of Healthcare Professionals or Heal-

thcare-related Professionals complied with the ethical principles set forth in this Code:

6.6.1. the location chosen for the event provides a suitable environment for the de-

velopment of the proposed scientifi c and educational topics, with conference rooms

and support material for presentations, workshops, and professional meetings.

Events in cruise ships or other locations with a primarily touristic appeal that may

corrupt the event’s technical-scientifi c character shall not be allowed;

1. Payment / reimbursement for fees that refer to the issuance of a passport and/or request for a travel visa for Health Pro-fessionals and/or Healthcare related Professionals when invited to participate in international events will not be permitted.


6.6.2. Expenses with transport, meals, and accommodation are limited to the event

itself and are related solely to the invited professional, and may be extended to the

days immediately before and immediately after the offi cial agenda, in case logistics

and transport issues justify such extension. The Companies shall keep a fi le with all

receipts, records, and documents related to the expenses made in name of the in-

vited professional for a time period equivalent to the respective fi scal year. The pay-

ment or reimbursement of any expenses by family members, companions or persons

invited by the Healthcare Professional or Healthcare-related Professional is expressly

forbidden;

6.6.3. Relationship actions destined to Healthcare Professionals or Healthcare-related

Professionals shall be modest and secondary to the scientifi c event, while the pay-

ment or reimbursement of any expense related to leisure activities, such as tickets to

shows, theatre, presentations, sports events etc. is expressly forbidden, regardless of

being linked to the organization of the scientifi c event;

6.6.4. any support to the participation of Healthcare Professionals and Healthcare-

related Professionals in national or international events shall not be conditioned to

the prescription, sale or promotion of any type of drug or Company by such profes-

sionals;

6.6.5. the invited Healthcare Professionals and Healthcare-related Professionals shall

not receive any type of remuneration, directly or indirectly, for the time invested to

participate in the event, except when such participation corresponds to services le-

gitimately provided due to a previous contractual obligation.

6.6.6. the offer of amenities by the Company during the events, including, but not

limited to lunches and snacks, shall be made in compliance with good conduct,

organization, and always compatible with the dignity and respectability of the par-

ticipating professionals.


Companies as organizers or holders of their own events

6.7.

The Companies may also hold their own events, with the purpose of disclosing new

drugs or promoting scientifi c knowledge among Healthcare Professionals or Healthca-

re-related Professionals.

6.7.1. events of this nature shall happen at the same country where the organizing

or holding Company is headquartered, except is the choice for a foreign country is

justifi able by reasons of security or logistics, such as in case of events that gather par-

ticipants from different countries or secondary events in international congresses.2

6.7.2. scientifi c events held by the Companies themselves shall be subject to the same

legitimacy and transparency requirements set forth in item 6.6 above.

6.8.

INTERFARMA encourages the adoption of measures and organization compatible with

the dignity and respectability of the professional class attending events held by it’s the

Companies, such as limiting the number of participants at events, previously defi ning

participation criteria, in addition to other measures considered relevant for the occa-

sion.

6.9.

The offer of fi rst-class tickets for Healthcare Professionals or Healthcare-related Profes-

sionals for participation in symposiums, congresses, seminars or professional meetings

of any nature is not allowed. The prohibition set forth in item 6.9 shall apply to events

held by the Companies themselves, by medical associations, by patient associations,

academies or any other public or private entities.

2. Merely economic issues cannot be considered when choosing the foreign country for hosting an event held by the Com-pany.


Section 7Promotional Materials

7.1.

Promotional Materials produced by the Companies in any format, physical or electro-

nic, shall comply with the following principles:

7.1.1. comply with the legislation in force and with the characteristics registered at

ANVISA at the time the material is produced;

7.1.2. be coherent and consistent with the visual, artistic, and copy plan;

7.1.3. present honest, impartial, and balanced data;

7.1.4. charts and illustrations shall properly support the copy they refer to;

7.1.5. medical and scientifi c information shall be clear, reliable, and updated, while

incorrect or ambiguous interpretations shall be avoided.

7.2.

All quotes, paraphrases, and medical and scientifi c information in the material shall

be based on reliable sources, such as offi cially acknowledged literature. Any data taken

from scientifi c publications shall be accompanied by the proper bibliographical refe-

rence, with at least the following information: author’s name, article’s title, periodical’s

name, publication year, volume number, and page numbers.

7.3.

The content of the bibliographical references shall be readily available to Healthcare

Professionals, sanitary authorities, and other qualifi ed professionals that request them.

7.4.

Third-party rights, especially copyrights, shall be strictly preserved.


7.5.

Any adaptation of charts from scientifi c publications shall be clearly informed (“adap-

ted from”) and strictly express the truthfulness of the study’s information, in addition

to the full bibliographical reference.

7.6.

Data from in vitro and animal studies shall be identifi ed as such and their results shall

not be extended to clinical practice.

7.7.

The use of images of children, pregnant women, naked bodies, and persons practicing

sports shall be careful and coherent with the characteristics of the promoted drug.

7.7.1. The use of uniforms from sports teams and/or professional athletes in con-

junction with the drug’s brand is not allowed.

7.8.

The material’s month and year of production shall be mentioned, including in adverti-

sing pieces.

7.9.

Comparative advertisement shall comply with the following principles and limits:

7.9.1. the use of third-party brands without consent of their respective owners is not

allowed;

7.9.2. it shall not confi gure unfair competition or vilify the image of drugs or brands

from other companies;

7.9.3. it shall not give rise to confusion between competing drugs;

7.9.4. the comparison shall be technically objective and supported; and

7.9.5. the comparisons and claims shall be provable and shall be accompanied by

supporting references.


7.10.

The comparison of data on adverse reactions or claims on supposed therapeutic supe-

riority of a drug over others are allowed only when strongly supported and duly proved

by indexed publications, with mention of the source that supports such statements.

7.11.

Claims of superiority in terms of effectiveness shall be allowed only when there is a sta-

tistically relevant difference, and clinical relevance shall also be considered.

Section 8Drug-related Activities at Points of Sales

8.1.

In order to preserve the consumer’s purchase intent and to respect the prescription, the

Companies shall not, directly or indirectly, give, promise or offer benefi ts and advanta-

ges of any nature, including bonuses, to Healthcare Professionals or Healthcare-related

Professionals, as well as to the general public.

8.2.

The marketing and advertising of prescription drugs towards non-pharmacist drugstore

owners, attendants or other persons unqualifi ed to dispense drugs is not allowed.

8.3.

Relationship actions that do not interfere negatively with the consumer’s freedom of

purchase, i.e., adherence programs and interactions aimed at informing Healthcare Pro-

fessionals or Healthcare-related Professionals, shall not confi gure violation of the rule

set forth in Section 8.


Section 9Communication on New Drugs and Indications not Approved by ANVISA (Offl abel)

9.1.

The Companies shall not promote, market, advertise or sell pharmaceutical products

if the conditions associated to such products, including new therapeutic indications or

mode of use have not been previously approved by ANVISA.

9.2.

The disclosure of information on unregistered, off-label indications or products may

only be carried out when related to medical and scientifi c information at congresses,

symposiums or other scientifi c events and provided that the audience is duly and pre-

viously informed that the product has not been registered or that the indication is off-

-label.

9.3.

Clinical studies related to products or indication still unregistered at ANVISA may be

handed out to Healthcare Professionals only upon their request.

9.4.

In case of international events, i.e., those in which a signifi cant number or lecturers

or guests from different countries take part, communications on new, off-label drugs

and indications may be carried out according to the approvals at the event’s country or

origin or other countries; in this case, it is mandatory to previously warn and inform

the Healthcare Professionals that such drug or condition has not been approved at the

country where the event is being held. Healthcare Professionals shall also be informed

about the country or countries where the mentioned product or indication is already

registered and approved for commercialization.


9.5.

The provisions of Section 9 shall not be applied in order to prevent the distribution

within the scientifi c community of relevant information on technological advances,

access to results of clinical researches, and new discoveries for the treatment of patients.

The disclosure of information on unregistered products shall also be allowed whenever

such disclosure is required by law or by a court ruling.

Section 10Off er of Gifts

10.1.

The Companies bound to this Code of Conduct may offer gifts to Healthcare Professio-

nals, provided the all the following conditions are complied with:

i) the gifts shall be objects related to medical practice and/or strictly educational, such

as, but not limited to publications, stand-alone issues of scientifi c periodicals (ex-

cept subscriptions), and anatomic models;3

ii) the gifts shall be objects of a merely symbolic value, i.e., objects whose individual

value is not higher than one third (1/3) of the national minimum wage at the time

of their acquisitions, and may or may not have the Company’s logo; and

iii) the offers of gifts are limited to three (3) events per year for each Healthcare Profes-

sional.4

3. For the purposes of item 10.1., “i”, the expression “publications” includes, but is not limited to, scientifi c notebooks and books, encyclopedias and manuals.Educational material, including, but not limited to, pamphlets, leafl ets, folders, posters and other non-personalized printed material with the objective of helping the Health Professional to properly orient the patient, will not be considered gifts, and are therefore excluded from the limits stipulated in item 10.1.Scientifi c/educational material delivered in compliance with legal demands will not be computed for purposes of item 10.1.

4. For determining compliance with the limitation established in item 10.1 “iii”, the Companies shall demonstrate mecha-nisms and/or best efforts were employed to control delivery of the gifts to Healthcare Professionals.


10.2.

Products used in the administrative routine of clinics, including, but not limited to

pens, pencil holders, and notepads shall not be considered objects related to medical

practice and, therefore, shall not be distributed as gifts. The prohibition set forth in

this item does not include the offer of pens and notepads used as support material by

participants in congresses, seminars or scientifi c lectures held outside the medical clinic

environment.

10.3.

Offers of gifts, advantages or any other items that do not meet the criteria defi ned above

and the legislation in force shall not be made under any circumstance.


Chapter 2Rules Related to Drugs Subject to a Physician’s Prescription


Section 11Distribution of Free Samples

11.1.

The distribution of free samples of drugs shall be made exclusively to prescribing pro-

fessionals and only at clinics, hospitals, and medical and dental clinics.

11.2.

The free samples of drugs shall contain at least 50% of the original presentation content

registered at ANVISA and traded by the Company, except for antibiotics, which shall

be in enough quantity for the patient’s treatment, and for contraceptives, which shall

contain 100% of the original presentation content registered at ANVISA and traded by

the Company.

11.3.

Offering samples to prescribing professionals in exchange for the prescription or sug-

gestion of products is not allowed.

11.4.

The distribution of free samples of vaccines, magistral preparations, and biological pro-

ducts that require special care for their conservation and transport, according to their

registration at ANVISA, shall not be allowed.

11.5.

For two (2) years after the expiration date of the lot of free samples, the Companies

shall keep a fi le with all documents related to the production, distribution, and phar-

macovigilance of free samples, containing at least the following information:

a. Record of drugs handed out to prescribing professionals as free samples;

b. Lot number of the distributed free samples, with nominal identifi cation and record

number at the respective councils of professionals who received such free samples;

c. Invoice with a description of the free samples’ presentation, including the lot num-

ber;


Section 12Visit to Healthcare Professionals5

12.1.

The activities of Company representatives shall be guided by the highest ethical and

professional standards, and their main purposes shall be to:

a. inform Healthcare Professionals on their products’ advantages and risks;

b. promote products according to the usage approved by local regulatory authorities,

providing all scientifi c evidence related to the drugs, supported by the respective stu-

dies; and

c. gather information from Healthcare Professionals on the acceptance of products and

possible adverse effects that may have been recorded.

12.2.

Company representatives shall provide Healthcare Professionals with precise and com-

plete information on drugs, always limited to the drug information and characteristics

registered at ANVISA.

12.3.

Healthcare Professionals shall not be offered incentives of any nature in exchange for

the prescription, suggestion, infl uence on the purchase decision or on the administra-

tion of products.

5. INTERFARMA does not agree with any sort of promise or authorization for payment and/or donation, as an instrument to permit access to professionals at Companies bound by this Code to offi ces, fi rst aid clinics, medical centers, hospitals and/or any other public or private health center.


12.4.

Buying meals to Healthcare Professionals is allowed when the purpose is to discuss or

exchange scientifi c or educational information; the values shall be modest and the lo-

cation suitable for the exchange of information. The Company’s representative shall be

present throughout the entire meeting.

12.5.

Buying meals or paying for any other expenses of companions is not allowed.

12.6.

There shall not be promotional actions for drugs directed towards students of medicine,

pharmacy and dentistry still not qualifi ed for prescription, in compliance with the pro-

fessional statute in force.

12.6.1. The handing out of scientifi c material to medical students shall be carried

out only during medical events and shall always be related to the main purpose of

disclosing and sharing relevant information for the improvement of continued edu-

cation in medicine.

Section 13Donations and Other Contribution for Healthcare Institutions, Bodies, Associations, and Companies

13.1.

Donations and other forms of contribution (“Contributions”) destined for Healthcare

Institutions, Bodies, Associations, and Companies shall be due to a legitimate interest

and always aimed at meeting the actual needs of the assisted community or society.

13.2.

Donations and contributions shall always be backed by a written document containing

at least their value, date, purpose, and possible charges.


13.3.

The Companies shall not use philanthropic donations and/or contributions as com-

mercial instruments or as product marketing strategies.

13.4.

Donations and contributions destined to Healthcare Institutions, Bodies, Associations,

and Companies shall be made only to formally established corporate entities, with the

purpose of promoting educational actions knowingly important for the wellbeing of

the assisted community or society, and shall not be used as a means to hold parties,

fraternizations or other entertainment events with no scientifi c and/or educational pur-

pose.

13.5.

The Contributions shall not be used as an instrument to obtain or retain business, with

the purpose of obtaining undue advantages, or be linked to retributions such as the su-

ggestion, recommendation or purchase of a Company’s products. Institutional promo-

tion shall be the only retribution allowed for Contributions provided by Companies.

13.6.

The Companies shall ensure that the receivers of their Contributions have sustainability

mechanisms that allow their existence regardless of Contributions.


Chapter 3Rules Related to Over-The-Counter Drugs (OTC)


Section 14Over-The-Counter Drugs (OTC)

14.1.

In addition to the provisions herewith and in the legislation in force, the advertising or

promotion of Over-The-Counter Drugs (OTC) shall comply with the following:

a) the consumer’s benefi t and safety shall always guide any advertising initiative;

b) the respect for consumers and Healthcare Professionals shall be the main basis of

promotional actions;

c) its main aim shall be to properly inform the consumers and Healthcare Professio-

nals; and

d) the promotional pieces shall highlight that the promoted products are drug, in order

to prevent any confusion with other freely consumable products.

14.2.

There shall not be the use of names, images and/or voices from persons unqualifi ed in

medicine or pharmacy, whose characteristics are easily recognizable by the public due

to their celebrity, to endorse, recommend or suggest the use of Over-The-Counter Drugs

(OTC), and neither the use of language that directly or indirectly relates the use of dru-

gs to physical, aesthetic, intellectual or psychological improvement, except when such

benefi ts can be proved.


14.3.

The promotion or advertising of Over-The-Counter Drugs:

14.3.1. shall not induce consumers to error regarding the product’s content, package

size, appearance, uses, rate of relief or actions;

14.3.2. any reference to scientifi c or consumer studies shall always be based on prop-

erly carried out and correctly interpreted researches, and the results or conclusions

presented to the consumer shall be provable;

14.3.3. shall not suggest the cure or prevention of any disease that requires treatment

under supervision of a Healthcare Professional;

14.3.4. shall not induce consumers to unnecessary use of drugs;

14.3.5. shall not induce children or teenagers to the use of the products;

14.3.6. shall not induce consumers to fear or concern that they are suffering or might

suffer from any serious disease;

14.3.7. shall not make any offer to return paid money or other benefi t of any nature

in case consumers are unsatisfi ed after purchasing a drug;

14.3.8. shall not contain any statement or presentation of any nature that may be

considered obscene, repulsive, rude or prejudicial in terms of race, gender, sexu-

al preference, belief, social or intellectual status, and shall not inspire violence or

spread superstition; and

14.3.9. shall not use messages, symbols, items, and images destined to encourage

the consumption of products by children or teenagers, and neither shall use playful

resources, such as games, toys, and dolls, for promotion purposes.


Section 15Direct Contact with Consumers

15.1.

Relationships with Consumers shall be kept through service centrals, websites, chats,

social networks or any other means of interaction, while Companies shall comply with

the following restrictions:

15.1.1. there shall not be suggestions of substitute or similar products for discontin-

ued or untraded products;

15.1.2. services exclusive of Healthcare Professionals shall not be provided;

15.1.3. there shall not be any justifi cation, denial or confi rmation or the treatment

or conduct of Healthcare Professionals, while the return to Healthcare Professionals

shall always be recommended; and

15.1.4. any medical data not mentioned in drug labels shall not be disclosed.

15.2.

General information on the prevention of diseases, healthy habits, and general health,

when not promotional, may be disclosed to the general public through consumer servi-

ce centrals or any other means of interactions.

15.3.

The contact with Consumers, when made by legally qualifi ed Healthcare Professionals

or Healthcare-related Professionals, shall comply with the rules related to their profes-

sional category.


Chapter 4Rules for Confl ict Resolution


Section 16Application and Eff ectiveness of Code of Conduct Rules

16.1.

INTERFARMA encourages Companies and any other interested persons or institutions

to present reasoned complaints against actions that may represent violations of the ru-

les set forth in this Code.

16.2.

Complaints presented by any interested Company, person or institution shall be recei-

ved by INTERFARMA for analysis of their consistency and possible investigation pro-

cedure. Once the complaint is admitted and the investigation procedure is opened, it

shall not be withdrawn, and the Ethics Committee shall be responsible for processing

the complaint, aiming at enforcing the applicable penalties.

16.3.

INTERFARMA shall not investigate anonymous complaints or complaints that do not

have enough elements to allow the complainant to be properly identifi ed.

16.3.1. Without prejudice to the above provision, the complainant may, in case of in-

dividuals and with a justifi able reason, request that their identity is kept secret from

the Parties and persons involved in the complaint, which shall be decided solely by

INTERFARMA’s CEO during the admission analysis.

16.4.

INTERFARMA shall only process complaints related to facts that have happened no

longer than one (1) year before the complaint is received by INTERFARMA. Complaints

fi led after such deadline shall be immediately archived, without possibility of appeal.


Section 17Ethics Committee

17.1.

The Ethics Committee shall be fully independent in regards to its prerogative to zeal

for strict compliance with the dispositions in this Code of Conduct by the Companies.

17.2.

The members of the Ethics Committee shall apply sanctions corresponding to each

case, in accordance with the highest standards of justice and equity, considering:

a. the seriousness of the violation;

b. the advantage obtained or intended by the violator;

c. completion or not of the violation;

d. the seriousness of damage, or risk of damage, to Companies, Consumers or third

parties;

e. negative effects in the pharmaceutical market;

f. aggravating or mitigating circumstances, as defi ned in item 18.5 below; and

g. the fi nancial power of the violating Company, based on its gross sales during the last

year, excluding taxes.

17.3.

The conditions to the constitution and operation of the Ethics Committee shall be de-

fi ned in its own regulations, which shall be an integral part of this Code of Conduct.

17.4.

INTERFARMA shall make its best efforts so that the processing and judging of com-

plaints is carried out in less than ninety (90) days, except for cases whose circumstances

and/or complexity justify a longer deadline.


Section 18Penalties

18.1.

The penalties defi ned in Section 18 are not progressive, and it is the role of the Ethics

Committee to enforce the measure necessary to ensure proper punishment to a viola-

tion, within standards consistent with the case’s circumstances.

18.2.

Without prejudice to the immediate interruption of the undue conduct, the Company

that violates the rules in this Code of Conduct shall be subject to one of the following

penalties:

18.2.1. Suspension of the Associated Company’s social rights before INTERFARMA

for up to one hundred and eighty (180) days, without right to suspend associative

contributions;

18.2.2. Exclusion of the Associated Company’s membership before INTERFARMA;

18.2.3. A fi ne to be defi ned according to the violation’s seriousness, taking into ac-

count possible mitigating and aggravating circumstances, according to the following

classifi cation:

a. Minor violations: from fi ve thousand Brazilian Reais (R$ 5,000.00) to eighty two

thousand and fi ve hundred Brazilian Reais (R$ 82,500.00).

b. Serious violations: from eighty two thousand and fi ve hundred Brazilian Reais

(R$ 82,500.00) to twenty two hundred thousand Brazilian Reais (R$ 220,000.00).

c. Very serious violations: from twenty two hundred thousand Brazilian Reais (R$

220,000.00) to one million, six hundred and fi fty thousand Brazilian Reais (R$

1,650,000.00).


18.3.

The penalties set forth in items 18.2.1 and 18.2.2 shall be applicable only to Compa-

nies that, at the time the penalty is applied, are bound to this Code of Conduct as one

of INTERFARMA’s Associated Companies.

18.4.

The amount paid by the Company as a fi ne shall be directly reverted to social welfare

organizations named by INTERFARMA. The donation, made in cash or converted in

assets of equivalent value, shall be punitive and shall not be included by the violating

Company in its balance sheet.

18.5.

The following shall be considered to determine the violation’s seriousness and the

amount to be paid as a fi ne:

18.5.1. Mitigating circumstances:

a. violator’s good faith;

b. the violator’s action was not essential for the event;

c. the violator, by their own will, immediately tries to repair or reduce the conse-

quences of the violation they are charged with; and

d. the violator has no previous record.

18.5.2. Aggravating circumstances:

a. the violator is recidivist; i.e., was found guilty by the Ethics Committee in the

last three (3) years, as of the publication of the last penalty, regardless of the

violation’s nature;

b. the violation had damaging consequences to public health;

c. if, being aware of the violation to this Code, the violator does not take measures

to prevent it; and

d. the violator acted with deliberation, recklessness, fraud or bad faith.


18.6.

If both mitigating and aggravating circumstances are present, the penalty shall be enfor-

ced considering those that are more relevant.

18.7.

INTERFARMA shall publish regularly on its website a report with information on the

activities of the Ethics Committee while investigating complaints of violations to this

Code of Conduct.


AnnexRegulation of the Ethics Committee


1. Preliminary provisions

1.1.

Any issues of violation to the Code shall be subject to the investigation procedure by

the Ethics Committee.

1.2.

Confl ict resolution by the Ethics Committee shall be limited solely to the judging and

enforcement of penalties set forth in the Code.

1.3.

The Ethics Committee’s meetings shall be held at INTERFARMA’s headquarters or at

another location previously defi ned by INTERFARMA, observing the meeting schedule

defi ned by the Committee’s appointed members.

1.4.

All documents, petitions and written communications shall be presented in a number

of counterparts corresponding to the number of members appointed to resolve the

confl ict, in addition to one counterpart for INTERFARMA and another for the accused

Company.

1.5.

Communications shall be sent to the address in INTERFARMA’s records – which shall

be constantly updated – and by any means that proves submission and receipt, such as,

but not limited to, e-mail, registered mail, fax or telegram.

1.6.

The deadlines set forth in this Regulation shall be counted in calendar days, shall start

on the fi rst business day after the receipt of communications, and shall include the

expiration day. If the expiration day is a holiday, the deadline shall be extended to the

next business day, whether at the location of INTERFARMA’s headquarters or at those of

any Company involved in the complaint.


2. Start of the investigation procedure

2.1.

Those who wish to fi le a complaint shall communicate such intent to INTERFARMA –

the “Communication” –, which shall verify if the information provided are formally

and materially consistent enough to allow the investigation procedure to start.

2.2.

The following requirements shall be met in order for a complaint to be considered for-

mally consistent:

2.2.1. identifi cation of the complainant and of the accused Company;

2.2.2. brief account of the supposed violation(s) to the Code, with relevant suppor-

ting documentation.

2.3.

The complaint’s material consistency shall consist in a preliminary examination, by

INTERFARMA’S CEO, of the truthfulness of the facts and that the issue is actually rela-

ted to the Code of Conduct.

2.4.

In case the complaint is considered formally and materially consistent, INTERFARMA

shall start the investigation procedure by sending a Communication to the notifi ed

Company regarding the conduct mentioned in the complaint, with a deadline of fi fteen

(15) days to submit a statement.

2.5.

In case the complaint is considered inconsistent, whether formally or materially, IN-

TERFARMA shall report to the complainant its reasoned decision and archive the com-

plaint, which shall automatically end the procedure, without possibility of appeal. A

complaint archived by INTERFARMA’s CEO may be fi led again by any interested party,

provided that the formal or material defects that justifi ed its archiving are remedied.


2.6.

Once the complaint is admitted, INTERFARMA shall not end the investigation procedu-

re due to refusal or non-appearance of any party.

3. The Ethics Committee

3.1.

The Ethics Committee is the collegial body responsible for judging complaints fi led

before INTERFARMA, being composed of representatives appointed by Companies and

outside professionals with proven experience, unblemished reputation and outstanding

knowledge of practices of the pharmaceutical industry.

3.2.

The Ethics Committee shall be an ad hoc body, meeting always with the specifi c purpo-

se of debating the case(s) included in the day’s agenda. Once the debates included in

the agenda are concluded, the Committee’s members shall be excused from their roles

in the Ethics Committee, but may be called upon in the future to debate new com-

plaints of violations to the Code of Conduct.

3.3.

In order to form the ad hoc Ethics Committee, INTERFARMA shall randomly choose

its members so that in a number that meets the quorum required for the Originating

Chamber or the Appellate Chamber, according to the jurisdiction and the profi le of

their respective members, observing the following parameters.

3.3.1. The Originating Chamber shall comprise up to six (6) members, of which:

• four (4) members shall be randomly chosen among the members appointed by

Companies; and

• two (2) members shall be randomly chosen among the outside professionals ap-

pointed by INTERFARMA.


3.3.2. The Appellate Chamber shall comprise up to ten (10) members, of which:

• seven (7) members shall be randomly chosen among the members appointed by

Companies; and

• three (3) members shall be randomly chosen among the outside professionals

appointed by INTERFARMA.

3.4.

Without prejudice to the above dispositions, the Ethics Committee may debate without

the full composition of its judging bodies, as long as there is a minimum quorum of:

• three (3) members for the Originating Chamber, of which at least two (2) shall have

been appointed by Companies; and

• fi ve (5) members for the Appellate Chamber, of which at least three (3) shall have

been appointed by Companies.

3.5.

In case a member cannot participate in a trial session, they should notify INTERFARMA

at least forty eight (48) hours in advance, as of their calling, so that a substitute may be

appointed. If the minimum quorum for debates set forth in item 3.4 above, INTERFAR-

MA may, at its discretion, opt not to choose a substitute member.

3.6.

In case it is not possible to reach the minimum quorum for debates, the session shall

be postponed and reschedule as soon as possible, while new members shall be ran-

domly chosen to replace the members disqualifi ed from their roles within the Ethics

Committee.

3.7.

The members who participate in the debates in the fi rst stage shall be disqualifi ed to

take part in the session called to decide the same case in stage of appeal.


3.8.

The members shall sign the Term of Independence, Impartiality, and Secrecy, and shall

deliver the signed document to INTERFARMA up to the date of the trial session.

3.9.

INTERFARMA’s CEO may determine the permanent replacement of any member who

fails to meet the deadlines and rules set forth in this Regulation.

4. Claim of impediment of a member

4.1.

Those who wish to claim the impediment of a member due to lack of independence

or any other reason shall do so before INTERFARMA, within two (2) business days as

of the moment when they become aware of facts or circumstances that support such

claim.

4.2.

Such claim of impediment shall be addressed to the members of the Ethics Commit-

tee assigned to analyze the specifi c case, by means of a reasoned petition and with the

relevant evidence. There shall be no appeal against a decision of the Ethics Committee

that determines the substitution of maintenance of a Member whose impediment has

been claimed.


4.3.

Members may be replaced if:

4.3.1. they cannot perform their role;

4.3.2. they are no longer part of the Company that appointed them to perform such

a role;

4.3.3. they are directly or indirectly linked to a Company that competes with any

party in the dispute, including the fact that their company has a competing product

in the class of the product mentioned in the complaint; or

4.3.4. they are in any of the situations set forth in the Term of Independence, Impar-

tiality, and Secrecy.

4.4.

Without prejudice to the above dispositions, the person called to be part of the Ethics

Committee shall always be encouraged to spontaneously disclose any fact that may give

cause to a justifi able doubt on their impartiality and independence.

5. Evidence

5.1.

Those that make a claim shall bear the burden of proof to support their arguments. The

Ethics Committee, at its discretion, may also request that the parties involved in the

issue provide additional evidence considered necessary or appropriate, in which case a

deadline compatible with their complexity shall be established.

5.2.

If the Ethics Committee requests or allows new evidence to be added to the original

complaint, the other party shall be notifi ed to fi le a statement on the new documents

within a maximum of fi ve (5) days.


5.3.

If a party duly called to provide evidence or to take any other measure fails to do so

within the deadline set forth by the Ethics Committee without providing a reason for

such, the Ethics Committee may decide based on the evidence already provided.

5.4.

The Ethics Committee may consult technical experts on specifi c issued related to the

complaint, or request that expert evidence is provided, whenever it deems this is in the

interest of a better decision on the issue. If a technical opinion or expert evidence is re-

quested, the parties shall have a joint deadline of fi ve (5) days to present their questions

and appoint technical assistants.

5.5.

The delivery of classifi ed material shall be subject to a specifi c decision by the Ethics

Committee in regards to its convenience and opportunity.

6. The trial session

6.1.

The trial session shall be held preferably at INTERFARMA’s headquarters, except if IN-

TERFARMA, in agreement with the parties, decides differently. Changes in the location

assigned for the trial session shall be previously reported to the parties.

6.2.

The trial session shall start on the assigned date; the Ethics Committee, the Originating

Chamber, and the Appellate Chamber shall be formed, depending on the case, obser-

ving the minimum quorum for debates.


6.3.

The Ethics Committee shall appoint the Chairperson, with powers to lead the procedu-

re as set forth in this Regulation. The Chairperson shall also have the deciding vote if

the members are not able to reach a majority decision on the analyzed issue.

6.4.

Once the session starts, the parties’ representative shall be requested to call up to two

(2) witnesses, at their discretion. The witnesses shall be heard by up to fi fteen (15)

minutes each, answering the questions they are asked by the parties and by the Ethics

Committee. The Chairperson shall act with the necessary prudence to respect the time

destined to hearing each witness and the preference in asking questions.

6.5.

After the witnesses have been heard, the parties’ representatives shall be invited to ver-

bal pleadings of up to ten (10) minutes each, fi rst the complainant, or INTERFARMA’s

representative in the Committee on behalf of the complainant, in case they have for-

mally requested their identity to be kept secret, and then the accused Company.

6.6.

Except for witness evidence, any other evidence shall only be presented during the trial

session under exceptional circumstances, to the discretion of the Ethics Committee,

observing the existence of circumstances that justify this. If new evidence is admitted

during the trial session, those against whom the evidence is presented shall request

the session to be suspended for analysis of the evidence, with fi ve (5) days to provide a

statement. The suspended session shall be restarted from the point of interruption, and

the Chairperson shall determine a new date within ten (10) days.

6.7.

Personal depositions and the hearing of witnesses may be carried out by videoconferen-

ce or by other means that use data, image, and voice communication technology.


6.8.

The absence of any party shall not prevent the Ethics Committee from deciding the

issue.

6.9.

Once the fi nding of facts is completed, the Ethics Committee shall decide the question

by simple majority, always based on accounts, evidence, and documents in the fi le. If

there is no majority agreement, the Chairperson’s vote shall prevail.

6.10.

Members who votes against the majority may, at their discretion, state their votes sepa-

rately.

6.11.

The decision made by the Ethics Committee shall be submitted to INTERFARMA by the

Chairperson of the Committee during that trial session. INTERFARMA shall notify the

parties of the decision on the business day after receipt, by sending a counterpart by

mail or any other means of communication, with proof of receipt, or event by directly

delivering it to the parties, upon a receipt.

7. The Decision of the Ethics Committee7.1. The decision made by the Ethics Committee shall include:

7.1.1. the abstract report, containing the names of the complainant and of the accu-

sed, as well as a summary of the issue;

7.1.2. the decision’s reasons, analyzing factual and legal issues;

7.1.3. the votes, the decision and the provisions based on which the members resol-

ved the issues that have been submitted;

7.1.4. the deadline for compliance with the decision and, if applicable, the condi-


tions for the accused Company to prove compliance with the penalty enforced;

7.1.5. signature of the members, of the parties’ representatives, and of two witnesses;

7.1.6. the decision’s date and location.

7.2.

In case any of the members or of the parties’ representatives cannot or does not wish to

sign the decision made by the Ethics Committee, the Chairperson shall certify such fact.

7.3.

The costs and expenses of the investigation procedure will be paid by the party that

gives rise to it., i.e., the claimant, if the claim is declared unfounded, or the accused, if

the claim is declared founded.

7.4.

Within fi ve (5) days from the receipt of notifi cation or from the personal knowledge of

the decision made by the Ethics Committee, the interested party, in light of the commu-

nication to the other party, may request that:

7.4.1. the Ethics Committee correct any material error possibly found in the decision;

7.4.2. the Ethics Committee clarify any obscurity or contradiction in the decision, or

to make a statement on an omitted issue which they should have decided.

7.5.

In the case mentioned in item 7.4 above, the Ethics Committee may hear the other

interested party on the arguments provided, within fi ve (5) days. Once the other party

has been heard or, if deemed irrelevant, once the petition has been received, the Ethics

Committee shall decide the request within ten (10) days, amending the decision if the

request is founded.


8. The appeal procedure

8.1.

There may be an appeal against a non-unanimous decision made by the Originating

Chamber of the Ethics Committee. The appeal shall be addressed to the Ethics Commit-

tee, to the care of INTERFARMA’s CEO, who shall take the measures required to open

the Appellate Chamber that shall decide the issue.

8.2.

The deadline for appeals shall be ten (10) days as of the awareness of the decision made

by the Originating Chamber, or of the decision on a request for review due to error,

obscurity or contradiction, if one has been fi led.

8.3.

The deadlines and procedures to open the Appellate Chamber shall be the same as for

the Originating Chamber, especially in regards to the conditions for operation of the

Appellate Chamber, for the claim of impediment of a Member, and for the procedures

for the trial session.

9. Eff ectiveness of the Decision of the Ethics Committee

9.1.

The decision made by the Ethics Committee binds the parties and their successors,

being converted, when applicable, in written evidence to support future substantive

actions or other legal actions.


10. Costs

10.1.

The parties may be called to pay the amounts determined by INTERFARMA as costs be-

fore the start of the conduct investigation procedure.

11. Confi dentiality

11.1.

Except when otherwise agreed or required by law, the Committee’s members shall keep

the confi dentiality of issues related to the arbitration. The confi dentiality commitment

shall also be excused in regards to already public information or information that has

somehow been disclosed before being transmitted to the members.

11.2.

INTERFARMA may disclose excerpts of the decision of the Ethics Committee on its we-

bsite or other means at its discretion.

11.3.

INTERFARMA shall be responsible for keeping the materials and documents it receives

during the procedure for three (3) years, as of the archiving of the procedure. After this

term, they shall be destroyed.

12. Final provisions

12.1.

INTERFARMA shall not be liable for any fact, action or omission of any nature related

to actions taken by the Ethics Committee, except when there is proof of deliberation or

bad faith in regards to the actions that are relevant to it.


Interfarma’s Associates


Allegations regarding a violation of the Code of Conduct may be sent by email to:

[email protected] or by mail to: Rua Verbo Divino, 1.488

7o andar Cj 7A – CEP 04719-904 – Chácara Santo Antonio – São Paulo – SP


Rua Verbo Divino, 1488 – 7º andar – cj. 7A

CEP 04719-904 – Chácara Santo Antônio – São Paulo – SP

Tel.: (55 11) 5180-3499 – Fax: (55 11) 5183-4247

w w w . i n t e r f a r m a . o r g . b r

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